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Summary: Fast growing division of a global medical device leader is for a Regulatory Affairs lead for new product introduction and support existing products. Requirements:Bachelors degree3-8 years experience with 510(k), CE-Marking and other Regulatory market approval submissions for Class II and III medical devicesGlobal regulatory submission experience highly preferredExperience working new products from initial development through commercializationExperience following trends in regulatory....


DIRECTOR / SENIOR DIRECTOR, REGULATORY AFFAIRS – CMC Our client, a progressive biopharmaceutical company, has a new opportunity for a Senior Director level Regulatory Affairs professional with CMC expertise in the San Francisco Bay area, to drive US and Global Regulatory projects. This is a full-time Senior Director level role with a primary focus on the discovery and development of oncology drugs. Independently manages all regulatory CMC business for oncology products throughout lifecycle.....


Global Pharmaceutical company in Northern New Jersey is expanding and looking for a Snr Clinical Operations Pharmacology Associate for a w-2 long term contract SR. Clinical Operations Associate- Clinical Pharmacology - Serve as operational study lead for assigned Clinical Pharmacology studies, participating in activities during pre-study, start up, conduct phase and close out - Ensure timely execution of studies in accordance with GCP and Allergan’s SOPs. - Assist in development of case report


Executive Director, Global Oncology Medical Affairs. Reporting the Chief Medical Officer, the Executive Medical Director will be accountable for the development and execution of the global medical affairs strategy. This physician will develop and lead the execution of global external engagement, communication and evidence generation strategies and will contribute to the overall global product strategy.This role is for a physician with at least ten plus years of oncology medical affairs....

- Newark, DE

Staff Biostatistician (Or Senior Staff - Depending on Level of Experience) East Coast (NY, NJ, or DE) Competitive Salary, Bonus, 6% 401K, 4 Weeks PTO, Excellent Benefits We have a newly created opening for an experienced Senior (Staff or Senior Staff Level) Biostatistician with a longstanding client; a multi-billion global medical diagnostics/instrumentation company. They have strong revenue growth, a stable environment, very low turnover, and offer the opportunity to work on customized,....

- Suburban Detroit, MI

Overview: The QA Director is responsible for the overall management of the quality assurance systems and related activities. This includes upholding and improving the quality management system and to promote both the awareness and adherence to customer and regulatory requirements.Top Accountabilities: 1. Ensure that the quality system processes and products comply with Federal and International Regulatory requirements. i.e., (ISO 13485/MDD, CMDR, FDA QSR). 2. Lead the maintenance and....


Accountability Objective: Responsible for the completion of assigned US Regulatory Submission and Compliance activities the company and its designated suppliers; coordinate assigned US and OUS regulatory reporting, such as MDRs, Vigilance Reports, Clinical Progress Reports, and Post-Approval Reports; provide support for: US and OUS regulatory submissions of new and existing products marketed by the company; assure compliance with US and OUS international regulatory requirements for Class III....


RETAINED SEARCH ASSIGNMENT Quality Assurance Validation, ManagerVMP – Validation to include: Facility, Utilities, Equipment, Computer, etc.QA Validation MgrMUST have Bio Pharma experienceManage Validation, Write Protocols,Manage EquipmentProject Manager for all Validation ProjectsResponsible that Validations are prepared and executedDesign Validation studies; USA & EUExecute CAPA action plan9CFRDegree BS a Science or relatedPrefer 2+ yrs supervision & experience designing and....


RETAINED SEARCH ASSIGNMENT Quality Assurance Validation, ManagerVMP – Validation to include: Facility, Utilities, Equipment, Computer, etc.QA Validation MgrMUST have Bio Pharma experienceManage Validation, Write Protocols,Manage EquipmentProject Manager for all Validation ProjectsResponsible that Validations are prepared and executedDesign Validation studies; USA & EUExecute CAPA action plan9CFRDegree BS a Science or relatedPrefer 2+ yrs supervision & experience designing and....

- Any US State

Validation Manager To manage all validation activities at the plant. This includes but is not limited to facility, equipment, cleaning, computer and process validation. This position will lead the site to ensure compliance to all applicable regulations and requirements. Ensures implementation of compliant validation master plan for the site and ensures all activities within the master plan are planned and executed. Writes, reviews and executes any required validation protocols to ensure....

- Any US State

Our client needs a doctor with experience in oncology clinical drug development to serve as a medical monitor. Work is estimated to take 10 hours per week to start.RequirementsMedical Doctorate (MD) or equivalent5 years clinical drug development experience in oncologyPhase 1 and phase 2 studiesResponsibilities1. Available to clinical investigator sites as a go-to person in the US for checking eligibility2. Be responsible for interacting with sites on safety management of the study. This will....


This is a key position that will have product development oversight responsibility for Design Control as the product moves through the development stages to commercialization. Key liaison between Product Development, Quality Engineering, and Regulatory Affairs. Maintain focus on VOC requirements as defined by Marketing. Required Background & Experience:MEDICAL DEVICE PRODUCT DEVELOPMENT EXPERIENCEBS degree in a technical discipline, preferably engineering. Advanced degree is a plus.Strong....


Are you a BC MD or DO BC by an Approved ABMS Board preferably in a primary care specialty (Internal Medicine, Med/Peds, Family Practice, Psychiatry, Pediatrics or Emergency Medicine) or other specialty (and familiar with Medicare patients) who is ready for a change? This is and outstanding opportunity for someone who is interested in working a Utilization Review role in the Kansas City, Kansas region. It is required you have a Pennsylvania license that is in good standing. It is a plus if you....

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